Peptide knowledge, connected to its evidence.

At a glance

What is it—and why does it matter?

Tesamorelin is a stabilized synthetic peptide designed as an analogue of hypothalamic growth hormone-releasing hormone (GHRH). Tesamorelin is described as selectively reducing visceral fat in the context of excess visceral abdominal fat in people living with HIV-1. The included evidence base consisted of randomized controlled trials in adults with HIV that evaluated tesamorelin against placebo. In the first 26 weeks, injection site reactions were reported in 25% on EGRIFTA and 14% on placebo.

Evidence behind this overview

[1][2][3][4]

Each sentence above is copied from a published claim presentation. The links open its evidence record.

ClassGrowth hormone–releasing factor analog

Structure44 amino acids

StatusFDA-approved ingredient

Products in this profile2

The important boundary

Not indicated for weight-loss management; it has a weight-neutral effect and long-term cardiovascular safety has not been established. [1]

Identity + structure

A molecule, not a product name.

Chemical identity and product identity are kept separate so evidence does not leak between formulations or indications.

Preferred name	Tesamorelin	Ingredient
Pharmacologic class	Growth hormone–releasing factor analog	Profile record
Peptide structure	44 amino acids	Profile record
Also indexed as	tesamorelin · tesamorelin acetate · GHRF analog	Search aliases

Mechanism + clinical pharmacology

Target, response, and disposition.

Primary explanation

Binds pituitary GHRH receptors and stimulates pulsatile growth hormone release, increasing downstream IGF-1. [1]

Evidence ledger

What the evidence says.

79 profile findings. Contextual and unclassified research is listed separately below. Open each citation to inspect the source and its limitations.

These are evidence statements, not individualized medical instructions. Product, dose, population, and study context remain attached to each source.

Study findings

What studies observed in defined populations, comparators, and time periods.

8 statements

Source-backed statement

Clinical study design (stated): two main studies enrolled 816 HIV patients with excessive abdominal fat; comparator was placebo; primary effectiveness measure was change in abdominal fat at 26 weeks.

Sources[10]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

Sources and study IDs describe provenance, not clinical strength. Several articles can report the same study; one study can support several distinct findings. No clinical strength rating has been assigned here.

2 cited passages across 1 source record.

Source-backed statement

Across included RCTs, tesamorelin was associated with a statistically significant reduction in limb fat mass, with mean difference -0.22 kg.

Sources[17]

Human research · design must be checked

1 cited source · Study independence not established

How to read this evidence

2 cited passages across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

In a reported adult case with central adiposity and BMI of 27 kg/m², tesamorelin treatment was associated with a marked reduction in waist circumference (WC).

Sources[19]

Human research · design must be checked

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

The application sought use in HIV patients with lipodystrophy who have excess abdominal fat.

Sources[10]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

The label explicitly states it is not indicated for weight loss management; it does not quantify weight change here.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

A meta-analysis of four RCTs in HIV-associated lipodystrophy reported a statistically significant reduction in visceral adipose tissue with tesamorelin 2mg, expressed as a pooled mean difference with a 95% confidence interval.

Sources[23]

Human research · design must be checked

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

Physiology (stated): growth hormone is reported to have a role in regulation of both adipose tissue formation and breakdown.

Sources[10]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Tesamorelin (EGRIFTA SV) has an FDA-labeled indication to reduce excess abdominal fat in HIV-infected adult patients with lipodystrophy.

Sources[7][8]

Regulatory record

2 cited sources · 2 regulatory records

How to read this evidence

2 cited passages across 2 source records.

Comparative evidence

How the studied intervention compared with another intervention, comparator, or threshold.

5 statements

Source-backed statement

Compared with SOC, tesamorelin produced a larger decrease in waist circumference, quantified as a median between-group difference of -2.7 cm with P = .015.

Sources[16]

Human research · design must be checked

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

The included evidence base consisted of randomized controlled trials in adults with HIV that evaluated tesamorelin against placebo.

Sources[17]

Human research · design must be checked

1 cited source · Study independence not established

How to read this evidence

3 cited passages across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

The pivotal studies used a placebo comparator.

Sources[10]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Between-group comparison of change in neurocognitive performance did not show a statistically significant difference (P = .673).

Sources[16]

Human research · design must be checked

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

The evidence synthesis included five randomized controlled trials that evaluated tesamorelin.

Sources[17]

Human research · design must be checked

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Mechanism

Source-backed statements about targets, pathways, and biological response.

10 statements

Source-backed statement

Mechanistically, tesamorelin is a GRF receptor agonist in vitro, showing similar potency to endogenous GRF at human GRF receptors.

Sources[7]

Animal / laboratory evidence

1 cited source · 1 regulatory record

Animal or laboratory findings do not establish benefit or safety in people.

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Mechanistically, tesamorelin acts as a GRF receptor agonist in vitro, showing similar potency to endogenous GRF at human GRF receptors.

Sources[7]

Animal / laboratory evidence

1 cited source · 1 regulatory record

Animal or laboratory findings do not establish benefit or safety in people.

How to read this evidence

2 cited passages across 1 source record.

Source-backed statement

The proposed pharmacologic action is GRF-mimetic stimulation of endogenous growth hormone secretion.

Sources[10]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

2 cited passages across 1 source record.

Source-backed statement

In lab testing, tesamorelin activates human GRF receptors similarly to natural GRF.

Sources[8]

Animal / laboratory evidence

1 cited source · 1 regulatory record

Animal or laboratory findings do not establish benefit or safety in people.

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Tesamorelin is described as an analogue of growth hormone-releasing hormone (GHRH).

Sources[22]

Human research · design must be checked

1 cited source · 1 linked study ID

How to read this evidence

2 cited passages across 1 source record.

Source-backed statement

The background proposes a potential pathway linking abdominal obesity to neurocognitive impairment involving visceral adiposity, inflammation, and reduced insulin-like growth factor 1 (IGF-1).

Sources[16]

Human research · design must be checked

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

Tesamorelin is described as selectively reducing visceral fat in the context of excess visceral abdominal fat in people living with HIV-1.

Sources[19]

Human research · design must be checked

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

Mechanistically, tesamorelin acts as a GRF receptor agonist in vitro, showing similar potency to endogenous GRF at human GRF receptors.

Sources[8]

Animal / laboratory evidence

1 cited source · 1 regulatory record

Animal or laboratory findings do not establish benefit or safety in people.

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

EGRIFTA WR increases growth hormone and raises IGF-1 in the blood.

Sources[8]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Mechanism (stated): tesamorelin is described as similar to human growth hormone-releasing factor (GRF), a hormone that stimulates release of growth hormone.

Sources[10]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Safety findings

Observed or labeled risks, adverse effects, and safety signals.

16 statements

Source-backed statement

In the first 26 weeks, injection-site reactions occurred in 25% with EGRIFTA vs 14% with placebo.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

After 26 weeks on EGRIFTA, 47% had IGF-1 above 2 SDS and 36% above 3 SDS; changes were seen as early as 13 weeks.

Sources[8]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

The long-term heart and blood vessel safety of EGRIFTA SV has not been established.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Clinical trial safety data report a higher incidence of injection site reactions during the first 26 weeks in EGRIFTA-treated patients compared with placebo-treated patients.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Tesamorelin (EGRIFTA WR) treatment was associated with more patients reaching HbA1c ≥ 6.5% by Week 26 versus placebo, with a reported hazard odds ratio quantifying increased diabetes risk.

Sources[8]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

In trials, tesamorelin (EGRIFTA) was associated with more patients reaching HbA1c ≥6.5% by Week 26 versus placebo, with an intent-to-treat hazard odds ratio of 3.3 (CI 1.4, 9.6).

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

In trials, 36% of patients had IGF-1 SDS >3 after 26 weeks, seen as early as 13 weeks.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Tesamorelin therapy (EGRIFTA) is associated with elevated IGF-1 standard deviation scores (SDS), with many patients exceeding 2 SDS and 3 SDS by 26 weeks, observed as early as 13 weeks.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Treatment with EGRIFTA is reported to elevate IGF-1: at 26 weeks, nearly half of patients exceeded 2 SDS and over one-third exceeded 3 SDS, with elevations reported as early as 13 weeks.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

In controlled trials, tesamorelin (EGRIFTA) had a higher incidence of injection site reactions than placebo during the first 26 weeks.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

By Week 26, HbA1c ≥6.5% occurred in 5% with EGRIFTA vs 1% with placebo; hazard odds ratio 3.3 (CI 1.4, 9.6).

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

The section lists example symptoms but does not quantify severity or timing.

Sources[8]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Because EGRIFTA SV induces endogenous GH release (GH is a known growth factor), the warning specifies not treating patients who have active malignancy.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Tesamorelin (EGRIFTA WR) increases GH production and elevates serum IGF-1; in reported clinical trial experience at 26 weeks, substantial proportions exceeded IGF-1 thresholds (>2 SDS and >3 SDS).

Sources[8]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Clinical trial safety data report more frequent HbA1c elevation to ≥ 6.5% with EGRIFTA than placebo by Week 26, with a reported intent-to-treat hazard odds ratio of 3.3 (CI 1.4, 9.6) for developing diabetes.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

In the first 26 weeks, injection site reactions were reported in 25% on EGRIFTA and 14% on placebo.

Sources[8]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Regulatory status

Product-, indication-, and jurisdiction-specific regulatory records.

9 statements

Source-backed statement

The marketing authorisation application for tesamorelin (Egrifta) was withdrawn by the applicant, as notified to the CHMP on 21 June 2012, for the intended indication of excess abdominal fat in HIV-associated lipodystrophy.

Sources[10]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Benefit–risk assessment (stated): CHMP’s opinion at withdrawal was an unfavorable benefit–risk balance for Egrifta.

Sources[10]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Regulatory: Ferrer Internacional, S.A. notified the CHMP on 21 June 2012 that it wished to withdraw its marketing-authorisation application for Egrifta in the indication of excess abdominal fat in HIV patients with lipodystrophy.

Sources[10]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Tesamorelin (EGRIFTA WR) has an approved indication for reducing excess abdominal fat in HIV-infected adult patients with lipodystrophy.

Sources[7][8]

Regulatory record

2 cited sources · 2 regulatory records

How to read this evidence

2 cited passages across 2 source records.

Source-backed statement

Regulatory assessment (stated): at the time of withdrawal, CHMP held a provisional negative approvability view for Egrifta in excess abdominal fat in HIV patients with lipodystrophy.

Sources[10]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Tesamorelin (EGRIFTA WR) has an approved indication to reduce excess abdominal fat in HIV-infected adult patients with lipodystrophy.

Sources[7][8]

Regulatory record

2 cited sources · 2 regulatory records

How to read this evidence

2 cited passages across 2 source records.

Source-backed statement

At withdrawal, the CHMP’s provisional view was that Egrifta could not have been approved for this use.

Sources[10]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Withdrawal rationale (stated by company): the application was withdrawn because CHMP considered the submitted data insufficient to conclude a positive benefit–risk balance.

Sources[10]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Programme impact (stated): the company reported to CHMP that withdrawal would have no consequences for patients currently in compassionate use programmes using Egrifta.

Sources[10]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Administration

Product-specific route, timing, formulation, and use instructions—not universal dosing advice.

9 statements

Source-backed statement

After mixing, each daily dose is 1.28 mg in 0.16 mL, and one mixed vial lasts 7 days.

Sources[8]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

After reconstitution, the labeled per-dose volume is 0.16 mL delivering 1.28 mg of tesamorelin.

Sources[8]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

The intended dosage form was a powder requiring reconstitution to prepare an injectable solution.

Sources[10]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

2 cited passages across 1 source record.

Source-backed statement

EGRIFTA WR reconstitution uses 1.3 mL of the provided diluent to yield a solution at 8 mg/mL.

Sources[8]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Inject EGRIFTA WR into the abdomen, rotate sites, and avoid scar tissue, bruises, and the navel.

Sources[8]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Reconstitution instructions specify adding 0.5 mL diluent to one vial of lyophilized EGRIFTA SV to obtain 2 mg/0.5 mL, using gentle rolling for 30 seconds and avoiding shaking.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

EGRIFTA SV reconstitution uses only Sterile Water for Injection; 0.5 mL diluent is added to 1 vial (2 mg/0.5 mL), and 0.35 mL is administered immediately after reconstitution.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Mix 1 vial with 0.5 mL diluent and roll gently for 30 seconds; do not shake.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

After reconstitution, each daily tesamorelin (EGRIFTA WR) dose is delivered as 1.28 mg in an injection volume of 0.16 mL.

Sources[8]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Dose records

Product- and indication-specific dose statements preserved separately to prevent unsafe generalization.

6 statements

Source-backed statement

Recommended dosing for tesamorelin (EGRIFTA WR) is a 1.28 mg subcutaneous injection once daily.

Sources[8]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

This dosing statement applies to the EGRIFTA SV 2 mg per vial formulation per the label.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

The recommended EGRIFTA WR dose is 1.28 mg injected under the skin once daily.

Sources[8]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

For EGRIFTA WR, the labeled recommended regimen is 1.28 mg administered subcutaneously once per day.

Sources[8]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

For the 2 mg per vial formulation, the labeled tesamorelin dose is 1.4 mg (0.35 mL of reconstituted solution) administered subcutaneously once daily.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

The prescribing information specifies a daily subcutaneous dose of tesamorelin (EGRIFTA SV) of 1.4 mg, delivered as 0.35 mL of reconstituted solution.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Studied populations

Who was represented in a study, label, or registry record.

1 statement

Source-backed statement

The proposed indication targeted excess abdominal fat associated with HIV-related lipodystrophy.

Sources[10]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Identity

Ingredient, molecule, and product identity statements.

15 statements

Source-backed statement

Tesamorelin is identified in the source with the name “Egrifta,” indicating an alternate name used for the same peptide.

Sources[18]

Human research · design must be checked

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

The sequence field provides a single component amino-acid sequence for tesamorelin: LRARAGREQNSEGQQRSMIDQLLKRASLQGLVKRYSNTFIADAY.

Sources[5]

Molecular / pharmacology evidence

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

Product composition/formulation: Egrifta contains tesamorelin as the active substance and was intended to be formulated as a powder for reconstitution into an injectable solution.

Sources[10]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Tesamorelin is described as an analogue of growth hormone–releasing factor (a peptide designed to mimic GHRF activity).

Sources[9]

Human research · design must be checked

1 cited source · 1 linked study ID

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Tesamorelin is classified as a growth hormone–releasing hormone (GHRH) analog.

Sources[19]

Human research · design must be checked

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

Tesamorelin is a synthetic analogue of human growth hormone-releasing hormone (growth hormone-releasing factor), meaning it is designed to mimic the endogenous peptide hormone.

Sources[14]

Human research · design must be checked

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

Tesamorelin is defined as a synthetic analog of human growth hormone-releasing factor, consisting of the native 44 amino acid GRF sequence modified by addition of a hexenoyl moiety at the N-terminal tyrosine residue.

Sources[7]

Regulatory record

1 cited source · 1 regulatory record

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

Tesamorelin is described as a synthetic analogue of growth hormone-releasing hormone (GHRH).

Sources[17]

Human research · design must be checked

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

In ChEMBL, tesamorelin is recorded under CHEMBL1237026, with preferred name TESAMORELIN and molecule type Protein.

Sources[5]

Molecular / pharmacology evidence

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

Tesamorelin is described as a GHRH analogue, meaning it mimics the activity/structure of endogenous growth hormone-releasing hormone.

Sources[23]

Human research · design must be checked

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

Tesamorelin is classified as a peptide ligand (Ligand ID: 6959) and has the INN tesamorelin.

Sources[12]

Molecular / pharmacology evidence

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

Tesamorelin is characterized as an analogue of growth hormone-releasing factor, indicating it is designed to mimic growth hormone-releasing factor activity.

Sources[13]

Human research · design must be checked

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

Tesamorelin is described as an analogue of growth hormone-releasing hormone (GHRH).

Sources[22]

Human research · design must be checked

1 cited source · 1 linked study ID

How to read this evidence

1 cited passage across 1 source record.

Source-backed statement

In this source, tesamorelin is categorized with growth hormone-releasing hormone (GHRH) analogues, within a group of unregulated peptides marketed as “research compounds” intended to modulate the growth hormone–insulin-like growth factor-1 (GH-IGF-1) axis.

Sources[21]

Human research · design must be checked

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Source-backed statement

Tesamorelin is a stabilized synthetic peptide designed as an analogue of hypothalamic growth hormone-releasing hormone (GHRH).

Sources[11]

Molecular / pharmacology evidence

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Additional research & classification gaps

13 archived statements are kept separate from drug-effect findings. Media studies, economic models, methods, and records with unresolved scope are not used as medical-effect evidence.

Inspect contextual research (13)

Trial registration · not results

2 cited sources · 1 regulatory record

How to read this evidence

2 cited passages across 2 source records.

Administration is once-daily self-administered subcutaneous injection.

Research context only—not evidence of a treatment effect.

These highlights do not include all the information needed to use EGRIFTA WR safely and effectively. See full prescribing information for EGRIFTA WR.EGRIFTA WR™ (tesamorelin) for injection, for subcutaneous useInitial U.S. Approval: 2010
Inject EGRIFTA WR into the abdomen. Rotate injection sites to different areas of the abdomen[see Warnings and Precautions (5.6)].
A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Tesamorelin (GHRH Analog) for Reducing Hepatic Steatosis in Adults With Metabolic Associated Steatotic Liver Disease (MASLD)
Study medication is self-administered once daily by subcutaneous injection.

Research context · scope unclassified

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

The authors explicitly cite insufficient statistical power and the absence of a placebo arm as study limitations.

Research context only—not evidence of a treatment effect.

Effects of Tesamorelin on Neurocognitive Impairment in Persons With HIV and Abdominal Obesity.
Recognizing the limitations of insufficient power and no placebo arm

Research context · scope unclassified

1 cited source · 1 linked study ID

How to read this evidence

1 cited passage across 1 source record.

The trial used double blinding and a placebo control in a pilot study design.

Research context only—not evidence of a treatment effect.

pubmed-42382101
In a double-blind, placebo-controlled pilot trial

Research context · scope unclassified

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Across 2 Phase 3 clinical trials and pooled analyses, tesamorelin produced statistically significant reductions in visceral adipose tissue (VAT) at 26 weeks.

Research context only—not evidence of a treatment effect.

Tesamorelin: a growth hormone-releasing factor analogue for HIV-associated lipodystrophy.
In 2 Phase 3 clinical trials and their pooled analyses, tesamorelin was proven to significantly decrease waist circumference and visceral adipose tissue (VAT) following 26 weeks of treatment.

Research context · scope unclassified

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Across 2 Phase 3 clinical trials and pooled analyses, tesamorelin produced statistically significant reductions in waist circumference at 26 weeks.

Research context only—not evidence of a treatment effect.

Tesamorelin: a growth hormone-releasing factor analogue for HIV-associated lipodystrophy.
In 2 Phase 3 clinical trials and their pooled analyses, tesamorelin was proven to significantly decrease waist circumference and visceral adipose tissue (VAT) following 26 weeks of treatment.

Research context · scope unclassified

1 cited source · 1 linked study ID

How to read this evidence

1 cited passage across 1 source record.

Outcomes included groupwise changes across physiological, behavioral, and neuroimaging domains (including morphometry and functional connectivity).

Research context only—not evidence of a treatment effect.

pubmed-42382101
We compared groupwise changes in body composition, fatigue, sleep, physical performance, glucose tolerance, cognitive function, and brain morphometry and functional connectivity.

Research context · scope unclassified

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Tesamorelin is stated to reduce abdominal obesity and increase circulating insulin-like growth factor 1 (IGF-1).

Research context only—not evidence of a treatment effect.

Effects of Tesamorelin on Neurocognitive Impairment in Persons With HIV and Abdominal Obesity.
Tesamorelin, a growth hormone-releasing hormone, reduces AO and increases IGF-1

Research context · scope unclassified

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Tesamorelin is an analogue of growth hormone releasing factor.

Research context only—not evidence of a treatment effect.

Tesamorelin: a growth hormone-releasing factor analogue for HIV-associated lipodystrophy.
To evaluate the efficacy and safety of tesamorelin, a growth hormone releasing factor analogue approved by the Food and Drug Administration in November 2010 for the treatment of lipodystrophy associated with HIV infection.

Research context · scope unclassified

1 cited source · 1 linked study ID

How to read this evidence

1 cited passage across 1 source record.

Tesamorelin is described as an analog of growth hormone–releasing hormone (GHRH).

Research context only—not evidence of a treatment effect.

pubmed-42382101
low-dose tesamorelin (1 mg; GHRH analog)

Research context · scope unclassified

1 cited source · 1 linked study ID

How to read this evidence

1 cited passage across 1 source record.

Tesamorelin is an analog of growth hormone-releasing hormone (GHRH), meaning it mimics GHRH activity.

Research context only—not evidence of a treatment effect.

pubmed-42382101
low-dose tesamorelin (1 mg; GHRH analog)

Research context · scope unclassified

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Tesamorelin is identified here as a growth hormone-releasing hormone (GHRH).

Research context only—not evidence of a treatment effect.

Effects of Tesamorelin on Neurocognitive Impairment in Persons With HIV and Abdominal Obesity.
Tesamorelin, a growth hormone-releasing hormone

Research context · scope unclassified

1 cited source · 1 linked study ID

How to read this evidence

1 cited passage across 1 source record.

This statement identifies tesamorelin’s drug class (a GHRH analog) but does not by itself establish clinical effects.

Research context only—not evidence of a treatment effect.

pubmed-42382101
low-dose tesamorelin (1 mg; GHRH analog)

Research context · scope unclassified

1 cited source · Study independence not established

How to read this evidence

1 cited passage across 1 source record. 1 publication group(s) lack a resolved study identity.

Tesamorelin acts as a growth hormone-releasing hormone analogue that stimulates synthesis and secretion of endogenous growth hormone.

Research context only—not evidence of a treatment effect.

Tesamorelin: a review of its use in the management of HIV-associated lipodystrophy.
that stimulates the synthesis and release of endogenous growth hormone.

Safety + tolerability

Risks, organized for scanning.

A structured orientation to the label—not a complete prescribing-information substitute or an individual risk estimate.

Contraindications

Disruption of the hypothalamic-pituitary axis
Active malignancy
Pregnancy
Hypersensitivity to tesamorelin or mannitol

Common effects

Arthralgia
Injection-site reactions
Pain in extremity
Peripheral edema
Myalgia

Serious risks

Elevated IGF-1
Fluid retention
Glucose intolerance or diabetes
Hypersensitivity
Malignancy considerations

Structured from current product labeling [1]

Products + regulatory context

Same ingredient. Different records.

Brand names, routes, presentations, indications, and instructions are product-specific. This table is an index—not a substitution guide.

Product	Form	Profile scope	Record
Egrifta WR	Daily subcutaneous injection	Reduction of excess abdominal fat in adults with HIV and lipodystrophy.	[1]
Egrifta SV	Daily subcutaneous injection	Same narrow indication; WR and SV are not substitutable.	[7]

Do not infer dosing, interchangeability, or an approved use from the ingredient name alone. Open the current label for the exact product and presentation.

Administration, interactions + monitoring

The practical clinical context.

Administration boundary: Daily subcutaneous product; Egrifta WR and Egrifta SV have different reconstitution and administration instructions and are not substitutable. [1]

Research status + gaps

What still needs better answers.

A useful knowledge base names uncertainty as clearly as it names findings.

No publishable claim yet for: contraindication, interaction
457 compiled claim(s) withheld by automated assurance: assurance_score_below_0.58 (259), assurance_score_below_0.72 (178), current_regulatory_source_required (94), extraction_ambiguity (196), high_risk_requires_regulatory_or_two_independent_sources (186), no_direct_support (434), proposal_not_staged (28)

How Peplexicon reads evidence

Authority: What kind of source is making the statement?
Independence: Do multiple citations represent separate studies—or the same evidence repeated?
Directness: Does the population, product, dose, outcome, and time horizon match the claim?
Consistency: Do credible sources support, qualify, or contradict one another?

References + discovery

Open the records yourself.

Authoritative records and published evidence are listed separately from live searches, which are discovery tools rather than pre-screened support.

Filter references

1
Regulatory labelEgrifta WR prescribing information
Current DailyMed label for the WR formulation, including non-substitutability language.
Open ↗
2
Literature indexEvery PubMed result for tesamorelin
Live National Library of Medicine literature search; results are not pre-screened or deduplicated.
Open ↗
3
Trial registryEvery registered study for tesamorelin
Live ClinicalTrials.gov search, including completed, active, and historical records.
Open ↗
4
Chemical recordtesamorelin chemical record
PubChem compound search from the National Library of Medicine.
Open ↗
5
Published evidence snapshotTESAMORELIN
chembl-molecule · T6
Published 2026-08-21 · retrieved 2026-08-21T17:03:42Z
Open ↗
6
Published evidence snapshotA Randomized, Double-Blind, Placebo-Controlled Phase II Study of Tesamorelin (GHRH Analog) for Reducing Hepatic Steatosis in Adults With Metabolic Associated Steatotic Liver Disease (MASLD)
clinicaltrials · T4
Published 2026-03-19 · retrieved 2026-08-28T12:18:09Z
Open ↗
7
Published evidence snapshotThese highlights do not include all the information needed to use EGRIFTA SV safely and effectively. See full prescribing information for EGRIFTA SV.EGRIFTA SV®(tesamorelin) for injection, for subcutaneous useInitial U.S. Approval: 2010
dailymed · T1
Published 2026-07-29 · retrieved 2026-08-18T22:03:56Z
Open ↗
8
Published evidence snapshotThese highlights do not include all the information needed to use EGRIFTA WR safely and effectively. See full prescribing information for EGRIFTA WR.EGRIFTA WR™ (tesamorelin) for injection, for subcutaneous useInitial U.S. Approval: 2010
dailymed · T1
Published 2026-07-29 · retrieved 2026-08-18T22:04:02Z
Open ↗
9
Published evidence snapshotMetabolic effects of a growth hormone-releasing factor in patients with HIV.
doi · T2
Published 2007-12-01 · retrieved 2026-09-08T21:45:50Z
Open ↗
10
Published evidence snapshotEgrifta | European Medicines Agency (EMA)
ema · T6
Published 2026-08-18 · retrieved 2026-08-18T22:04:00Z
Open ↗
11
Published evidence snapshotIUPHAR ligand commentary
iuphar-comments · T6
Published 2026-08-21 · retrieved 2026-08-21T17:03:42Z
Open ↗
12
Published evidence snapshottesamorelin
iuphar-ligand · T6
Published 2026-08-21 · retrieved 2026-08-21T17:03:42Z
Open ↗
13
Published evidence snapshotLong-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation.
pubmed · T2
Published 2008-09-12 · retrieved 2026-09-08T21:45:43Z
Open ↗
14
Published evidence snapshotTesamorelin: a review of its use in the management of HIV-associated lipodystrophy.
pubmed · T3
Published 2011-05-28 · retrieved 2026-09-09T23:04:36Z
Open ↗
15
Published evidence snapshotTesamorelin: a growth hormone-releasing factor analogue for HIV-associated lipodystrophy.
pubmed · T3
Published 2012-02-01 · retrieved 2026-09-09T23:04:38Z
Open ↗
16
Published evidence snapshotEffects of Tesamorelin on Neurocognitive Impairment in Persons With HIV and Abdominal Obesity.
pubmed · T2
Published 2025-06-02 · retrieved 2026-09-01T10:53:44Z
Open ↗
17
Published evidence snapshotBody composition, hepatic fat, metabolic, and safety outcomes of Tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: A meta-analysis of randomized controlled trials.
pubmed · T2
Published 2026-01-01 · retrieved 2026-08-18T22:03:54Z
Open ↗
18
Published evidence snapshotSafety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance.
pubmed · T3
Published 2026-08-01 · retrieved 2026-08-17T23:10:15Z
Open ↗
19
Published evidence snapshotDiffering Presentations of Excess Visceral Abdominal Fat in People Living With HIV: Two Clinical Cases Highlighting Distinct Therapeutic Pathways With Tesamorelin and Glucagon-Like Peptide-1 Receptor Agonists.
pubmed · T3
Published 2026-05-15 · retrieved 2026-09-05T08:43:42Z
Open ↗
20
Published evidence snapshotpubmed-42382101
pubmed · T3
Published 2026-08-17 · retrieved 2026-08-17T23:10:15Z
Open ↗
21
Published evidence snapshotThe emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration.
pubmed · T3
Published 2026-01-01 · retrieved 2026-08-17T23:10:15Z
Open ↗
22
Published evidence snapshotpubmed-42419889
pubmed · T3
Published 2026-08-17 · retrieved 2026-08-17T23:10:15Z
Open ↗
23
Published evidence snapshotEfficacy and Safety of Tesamorelin in People Living With HIV (PLWH) With Lipodystrophy: A Systematic Review and Meta-Analysis.
pubmed · T2
Published 2026-01-01 · retrieved 2026-08-25T08:39:52Z
Open ↗